Brexit – Information to marketing authorisation holders of nationally approved medicinal products
- Published: December 15, 2020
- Last updated: December 15, 2020
Since 1 February 2020, the United Kingdom has become a ‘third country’ to the EU. In accordance with the Withdrawal Agreement EU law in its entirety applies to and in the United Kingdom during a transition period. As from the end of the transition period on 31 December 2020, the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) will apply from 1 January 2021.
The Medical Products Agency reminds MA Holders to make the necessary changes until 31 December 2020 to ensure that their authorised medicinal products comply with EU law and can remain on the EU market after the transition period. Practical guidance for procedures related to Brexit for medicinal products approved via MRP/DCP can be found on the Brexit websites of CMDh and CMDv respectively.
There is also a need for MA Holders to familiarise themselves with the applicable rules in Northern Ireland as specified in the IE/NI Protocol and update their marketing authorisations as needed. More information on the IE/NI Protocol can be found in the Notice to stakeholders - withdrawal of the United Kingdom and EU rules for medicinal products for human use and veterinary medicinal products (PDF) published by the European Commission in March 2020. Practical guidance on the implementation of the IE/NI Protocol for medicinal products approved via MRP/DCP is expected shortly from CMDh and CMDv.
MA Holders are also referred to the EMA Questions and answers to stakeholders on the implementation of the Protocol on Ireland/Northern Ireland (PDF) with respect to EMA activities that includes nationally approved medicinal products, e.g. Article 57 database, EudraVigilance, electronic application forms and PSUR repository.
Parallell import
The Withdrawal Agreement also describes the rules for goods that have been placed on the market before the end of the transition period. A good lawfully placed on the market in the EU or the United Kingdom by 31 December 2020 may, according to the interpretation of the Medical Products Agency, be further made available on the market of the EU or of the United Kingdom and circulate between these two markets until it reaches its enduser throughout its shelf-life. An approved licence to sell a parallel imported medicinal product alone, does not mean that the product can continue to be imported; the product also has to have been released to the market in the EU or the UK by 31 December 2020 as mentioned above.
According to the interpretation of the MPA, parallel import from Northern Ireland will continue to be allowed according to the IE/NI Protocol, part of the withdrawal agreement. However, parallel importers should note the restrictions based on the intellectual property laws, which also need to be considered (EC Notice to stakeholders on exhaustion of intellectual property rights (PDF)). Based on the outcome of the ongoing negotiations, the position of the MPA may change.